Start of mission
November 18, 2019
Type of contract
CDD/ Fixed Term Contract
Overall Objectives and Purpose of the roleIn the Clinical Development Department, reporting to the Senior Director Regulatory Affairs, you will be a core team member within a matrix organization.
You will be responsible for providing specific regulatory affairs leadership and support for a new biological product at the stage of registration in Europe and in Switzerland. You will also responsible for the maintenance of the MA (lifecycle management including variations / amendments, renewals, line extensions...). Note that these activities are managed at the global level.
Within the regulatory team, your main mission and responsibilities are the following:
Main responsibilities and key tasks
- Participation of an EU centralized Marketing Authorisation Application (MAA) procedure and Swiss MAA under the responsibility of the Senior Director, Regulatory Affairs and in collaboration with an external partner.
- Maintenance of the Marketing Authorisation (MA) (annual re-assessment, variations).
- Revision of approval documents and text management (labeling management) including tracking of updates and implementation.
- Validation of packaging artworks, labels to ensure compliance to applicable regulations.
- Participation in the review/validation process for promotional documents and educational documents according to current internal procedures and applicable regulations.
- Maintaining/developing knowledge of global competitive landscape, regulatory environment, and regulations.
- Managing the regulatory Contract Research Organisations (CROs) for coordination and preparation of submissions, if applicable.
- Collaboration with regulatory affairs representatives in the European structure (internal or external; Business unit or national entities).
Experience and QualificationsEssential:
- A university degree in biomedical sciences, preferably at Pharm. D or PhD level.
- 5 years' pharma industry experience in regulatory affairs with experience in the submission and approval of EU oncology products.
- Extensive knowledge of preparing applications and the handling of centralized procedures in the EU and application procedures in Switzerland.
- At least 3 years of experience in Regulatory Affairs, ideally for an ‘exploitant' Company.
- Strong working knowledge and understanding of biologics (mAbs) compounds is highly desired.
- Hands-on experience in coordinating MAA submissions, and authorities' interactions through approval.
- Experience and knowledge in the preparation of major regulatory submissions.
- Experience in leading and providing regulatory input to cross functional project teams.
- Knowledge of current pharmaceutical and regulatory requirements in the EU and in Switzerland.
- Understanding of the Good Clinical Practice (GCP) regulations, ICH guidelines, Clinical Trial Regulation (CTR) and internal SOPs.
- Sound understanding of the regulatory and quality issues related to an 'exploitant' company.
Additional Skills/ Behaviours
- Strong ability to work independently as well as in a team matrix organization with little or no supervision, interacting with several stakeholders (internal and external) and building meaningful relationships at all levels.
- Excellent communication skills, both verbal and written.
- Detail oriented with accuracy, clarity and unambiguous.
- Ability to be flexible (multi-task) and adapt to different situations quickly, and in a biotech environment
- The applicant must be able to read, write and speak French and English (multi-lingual an advantage).
- Problem solving capabilities - able to seek solutions and identify efficiencies.